Radiological mixture and method of preparing the gastro-intestinal system for x-ray photography

ABSTRACT

A DRY, SOLID RADIOPAQUE MIXTURE SUITABLE FOR THE PREPARATION OF AN ENEMA THEREFROM BY ADDING A LIQUID THERETO COMPRISING A WATER DISPERSIBLE CONTRAST MEDIA IN A DRY STATE AND A WATER SOLUBLE, SOLID, PARTICULATE, POLAR COATING AGENT HAVING THE PROPERTY OF INCREASING THE COATABILITY OF THE CONTRAST MEDIUM ON THE WALL OF THE INTESTINE, PREFERABLY A WATER SOLUBLE SOAP, THE COATING AGENT BEING PRESENT IN AN AMOUNT EQUAL TO ABOUT .03 TO 4% BY WEIGHT OF THE CONTRAST MEDIA IN THE MIXTURE. IN A METHOD OF PREPARING THE GASTRO-INTESTINAL SYSTEM FOR X-RAY PHOTOGRAPHY COMPRISING ADMINESTERING AN ENEMA CONTAINING A DISPERSION OF A CONTRAST MEDIA AND A SOAP SOLUTION IN WHICH THE SOAP IN SOLUTION IS ABOUT .03 TO 4% BY WEIGHT OF THE CONTRAST MEDIA IN THE DISPERSION.

United States Patent Int. Cl. A61k 27/08 US. Cl. 4244 3 Claims ABSTRACT OF THE DISCLOSURE A dry, solid radiopaque mixture suitable for the preparation of an enema therefrom by adding a liquid thereto comprising a water dispersible contrast media in a dry state and a water soluble, solid, particulate, polar coating agent having the property of increasing the coatability of the contrast medium on the wall of the intestine, preferably a water soluble soap, the coating agent being present in an amount equal to about .03 to 4% by weight of the contrast media in the mixture.

In a method of preparing the gastro-intestinal system for X-ray photography comprising administering an enema containing a dispersion of a contrast media and a soap solution in which the soap in solution is about .03 to 4% by weight of the contrast media in the dispersion.

This invention is directed to a new and improved mixture and method for preparing the gastro-intestinal system for X-ray photography.

Radiology is the branch of medicine that deals in part with the use of X-rays in the diagnosis of disease. Internal organs into which a suitable contrast medium has been introduced appears most distinctly in X-ray photographs. The clinical usefulness of the X-ray examination of certain internal organs (e.g. stomach and the intestines) depends in large measure on the used a contrast medium, usually barium sulphate, which is introduced into the organs by various means and which makes the organ show up distinctly in the photograph.

The contrast medium or radiopaque medium is generally introduced into organs such as the large and small intestine by the use of an enema administration set. When administered to the stomach, it is administered orally usually with flavoring added. In taking X-rays of the large intestine, the large intestine is first irrigated with the enema containing the contrast media and X-rays are then taken. Generally the diagnosis of the large intestine also includes the taking of X-rays after evacuation of the bulk of the contrast suspension, but while the Walls of the large intestine are still coated with the radiopaque suspension. This is generally termed an air contrast or post evacuation study and to accomplish the same the large intestine is pumped full of air.

Although radiologists have been using such post evacuation studies for a number of years the definition of the X-rays obtained have not always been sufficient for diagnostic purposes.

A serious problem with such studies has been the difficulty in uniformly achieving adequate and uniform adherence to, and coating of, the mucosa of the large intestine by the water insoluble radiopaque material to uniformly provide the high quality X-ray photographs desired. Consequently, the X-ray results are often inferior and the studies often have to be repeated at additional expense and inconvenience to the patient. In many cases accurate diagnosis has not been possible because of this difficulty. Further, the radiopaque solid material tends to settle out in the patient after evacuation but before and 3,590,115 Patented June 29, 1971 during X-raying, which deleteriously affects the X-ray results.

Accordingly, there has existed for many years a need for an improved radiopaque formulation which would uniformly adhere to and uniformly coat the mucosa of the large intestine, particularly after evacuation of the radiopaque enema composition to thereby insure the uniform obtaining of X-ray photographs suitable for exacting analysis.

An object of the invention is to provide such a formulation to thereby satisfy this long felt need.

Another object of the invention is to provide such a formulation in the form of a dry mixture to which a liquid may be added to prepare a radiopaque enema.

Yet another object is to provide such a dry mixture prepackaged in a disposable plastic bag to which such liquid is added just prior to use and from which the resulting enema is dispensed.

A further object is to provide a new and improved method and enema for coating the walls of the large intestine with radiopaque material prior to taking X-ray photographs of the same.

Still other objects and advantages of the invention will in part be obvious and will in part be apparent from the specification.

The invention accordingly comprises the steps and the relation of one or more of such steps with respect to each of the others, and the composition and mixture, the features, properties, and the relation of constituents or components, which are exemplified in the following detailed disclosure, and the scope of the invention will be indicated in the claims.

The invention is in general a radiopaque mixture in a dry state from which an enema or the like may be prepared by the addition of a liquid, preferably water, thereto. The mixture contains a radiopaque contrast media such as barium sulphate in a dry state, generally in a powder form, such that it is readily dispersible in water to form a dispersion therefrom. In addition the mixture includes a water soluble, solid, particulate, polar coating agent having the property of increasing the coatability of the contrast medium on the mucosa of the intestine, preferably a water soluble pharmaceutically acceptable, normally solid soap in a dry state, preferably in a powder form so that it is readily soluble in water. The term pharmaceutically acceptable connotes soaps that may be administered to the human body.

The term soap as used in this application is defined as a water soluble salt of a long chain of fatty acid, usually made by saponification of a vegetable oil with caustic soda. Examples of such soaps is given in the text Organic Chemistry, by Morrison and Boyd published by Allyn and Bacon, Inc., Bostonand copyrighted in 1959, on pages 493-496 thereof, the disclosure of which is incorporated herein by reference. The preferred soap utilized in this invention is castile soap which is a sodium salt made from olive and/or coconut oil.

It has been unexpectedly found that by using a contrast medium mixture containing soap in an amount of about .03 to 4%, more preferably 1 to 3 /2%, by weight of the contrast medium and thereafter administering the mixture in the form of an enema, increased coating and adhesion of the contrast medium to the walls of the organs of the gastro-intestinal system are achieved.

The discovery is of primary importance in X-ray examinations of the large intestine. As noted above, in examining the large intestine, an enema is administered using an enema bag prior to taking X-ray pictures of the intestine. X-ray procedures utilized at the present time also include evacuating the large intestine and thereafter taking additional photographs of the large intestine while the walls of the intestine are still coated with the contrast media. Very often, the coating (thickness )of the contrast media remaining on the walls of the large intestine has not been sufiicient to provide well defined X-ray photographs. By utilizing an enema prepared from the mixture of this invention, it has been found that the contrast media remains as a coating on the walls or mucosa of the large intestine in an amount sufficient to obtain fine definition X-ray photographs.

In this invention, the enema is preferably prepared just prior to use from a dry mixture of the soap and contrast media by adding tap water thereto while in a plastic enema bag (such as shown in US. Pat. No. 3,306,327 issued to John C. Hg), in which the dry mixture is packaged for shipment, and then agitating and mixing the same while in the enema bag to form a suspension of the contrast media and a solution of the soap. It has been found by adding a liquid soap rather than a dry solid soap to the contrast medium, clumping of the contrast medium, as well as precipitation of the contrast media, occurred. Accordingly, it was very difficult to form a dispersion of the contrast media in water which would be suitable for administration to a patient. The clumping of the contrast media has been to such an extent that the enema tube used to administer the enema as well as the rectal tip would clog.

It has also been found that if substantially less or more than the amount of soap by weight as indicated herein is used in the mixture, coating of the walls of the organ is not achieved or clumping of the contrast media occurs in the bag used for preparing the enema. Also surprisingly enough, if such amount of soap is exceeded, the patient may be unable to comfortably evacuate the enema mixture because of excessive adhesion.

After mixing of the constituents to prepare the enema, the enema is then used to irrigate the large intestine in the usual manner prior to taking X-ray photographs.

A preferred mixture for preparing radiological enemas according to this invention comprises barium sulphate in its dry particulate state together with solid particulate castile soap intimately admixed with each other.

The preferred amount of castile soap is about .03 to 4% by weight of barium sulphate. For example, an enema was prepared by adding 2000 cc. of water to a plastic enema applicator bag containing 397.6 grams of particulate barium sulphate and 5 grams of powdered castile soap and then kneading and agitating the bag until a dispersion of barium sulphate is formed and a solution of the castile soap is formed. The prepared enema was administered to the bowel of a patient and X-rays taken of the bowel containing the enema after which the enema was evacuated followed by introducing air in conventional fashion in to the bowel and then taking further X-rays. This was repeated for a number of patients and in every case the X-ray photographs were excellently clear and sharp. The post evacuation X-rays showed that an excellent and uniform coating of radiopaque material was consistently formed on and was retained by the wall of the intestine without any substantial settling in the bowel after evacuation.

It should be understood that the enema may contain other materials such as laxative and tanning components, as well as conventional dispersing agents such as carboxy methyl cellulose, normally a part of radiological enemas.

In the practice of this invention the X-ray equipment, film or fluoroscope screen and the procedure for taking the radiograph such as the time of exposure, positioning of the person or animal and the like is the same as that used in the conventional and acceptedradiographic practice.

While preferred embodiments of the invention have been disclosed and described, it is to be understood that changes and variations may be made without departing from the spirit and scope of the invention.

What is claimed:

1. In a method of preparing the gastro-intestinal system for X-ray photography, wherein barium sulfate is employed as the X-ray contrast media, the improvement comprising introducing into the gastro-intestinal system a water dispersion made by dispersing in water a composition consisting essentially of a solid dry powder mixture of a water dispersible, water insoluble, dry barium sulfate powder and a water soluble dry powdered sodium soap of a long chain fatty acid, the amount of soap being between 0.03 and 3.5% by weight of the barium sulfate, the amount of said dispersion introduced into said system being suflicient to coat the portion of said gastro-intestinal system into which said dispersion is introduced.

2. The method of claim 1, wherein said soap is castile soap.

3. The method of claim 1, wherein said soap is derived from the saponification of a vegetable oil.

References Cited UNITED STATES PATENTS 249,462 11/1881 Doepp 4243 18 2,940,996 6/1960 Papa 424--5 3,236,735 2/1966 Brown 4244 3,247,841 4/ 1966 Cook 4244 ALBERT T. MEYERS, Primary Examiner F. E. WADDELL, Assistant Examiner 

